Febuxostat-Controlled, Double-Blind, Comparative Study of FYU-981 in Hyperuricemia With or Without Gout

Hyperuricemia With or Without Gout Clinical Trial

Official title:

Febuxostat-Controlled, Double-Blind, Comparative Study of FYU-981 for Hyperuricemia With or Without Gout to Evaluate the Safety and Noninferiority of FYU-981 (Phase III Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03372200
• Other study ID #: FYU-981-014
• Status: Completed
• Phase: Phase 3
• Start date: January 9, 2018
• Est. completion date: July 5, 2018

Study information

• Verified date: September 2018
• Source: Mochida Pharmaceutical Company, Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

FYU-981 or Febuxostat are administrated to hyperuricemia patients (underexcretion and mixed types) with or without gout for 14 weeks to compare the efficacy and safety of these drugs by the method of multicenter, randomized, double-blind, ascending dose regimen.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 203
• Est. completion date: July 5, 2018
• Est. primary completion date: June 4, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Serum urate level:

• >= 7.0mg/dL in patients with gouty nodule or with history of gout, or >= 8.0mg/dL in patients with hypertension, diabetes or metabolic syndrome, or >= 9.0mg/dL

• Disease type in the classification of hyperuricemia: Uric acid-underexcretion type or mixed type

• Outpatients

Exclusion Criteria:

• Gouty arthritis within 14 days before randomized allocation

• Secondary hyperuricemia

• HbA1c: >= 8.4%

• Clinically significant cardiac, hepatic, renal, hematologic or endocrine disease

• Kidney calculi or clinically significant urinary calculi

• AST: >= 100 IU/L or ALT: >= 100 IU/L

• eGFR: < 30 mL/min/1.73m^2

• Systolic blood pressure: >= 180 mmHg or diastolic blood pressure: >= 110 mmHg

Related Conditions & MeSH terms

• Gout
• Hyperuricemia
• Hyperuricemia With or Without Gout

Intervention

Drug:
• FYU-981
Oral daily dosing for 14 weeks
• Febuxostat
Oral daily dosing for 14 weeks

Locations

Country	Name	City	State
Japan	Mochida Investigational sites	Tokyo

Sponsors (2)

Lead Sponsor	Collaborator
Mochida Pharmaceutical Company, Ltd.	Fuji Yakuhin Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent reduction from baseline in serum urate level at the final visit	Percent reduction from baseline in serum urate level at the final visit	14 weeks